A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this study are to evaluate the safety and efficacy of OSI-461 in CLL patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: OSI Pharmaceuticals

Criteria

Inclusion Criteria:

• Diagnosis of CLL established by bone marrow aspiration and biopsy or flow cytometry of peripheral blood.

• No previous therapy for CLL.

• Expected remaining life span greater than or equal to six months.

• 18 years or older.

• Willingness and ability to sign an informed consent.

Exclusion Criteria:

• Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.

• History of other malignancy which could affect the diagnosis or assessment of OSI-461.

• Previous therapy for CLL.

• Use of an investigational medication or device within one month of initiating study therapy.

• Concurrent immunotherapy.

• Use of steroids at the time of enrollment (patients who require steroids after enrollment may remain on study).

• Any condition or any medication which may interfere with the conduct of the study.

• Serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.

• Evidence of CNS involvement.

• Pregnant or nursing women.